D-0277-2019 Class II Terminated
FDA drug recall D-0277-2019 was initiated by Taro Pharmaceuticals U.S.A., Inc. on Oct 19, 2018 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. The recall status is terminated (terminated Nov 3, 2020). Affected quantity: 8328 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 21, 2018
- Initiation Date
- Oct 19, 2018
- Termination Date
- Nov 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8328 bottles
Product Description
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
Reason for Recall
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 313345, Exp 12/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0277-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026